1. Technical Field
This invention relates to a polymorph of a p38 MAP kinase inhibitor useful for treating cytokine mediated diseases.
2. Background Information
p38 MAPK is an integral enzyme necessary for the generation of many pro-inflammatory cytokines, eg., TNF-α in vitro and in vivo. Inhibitors of this enzyme would therefore be useful in treating cytokine mediated diseases. A potent inhibitor of this enzyme, BIRB 796 BS, is described in U.S. Pat. No. 6,319,921, example no. 8.
1-(5-tert-butyl-2-p-tolyl-2H-pyrazol-3-yl)-3-[4-(2-morpholin-4-yl-ethoxy)-naphthalen-1-yl]-urea (hereinafter, “BIRB 796”).
U.S. Pat. No. 6,583,282 and related U.S. patent application Ser. No. 10/300,448 disclose conditions which produce a single polymorph known as Form IV. The same polymorph Form IV is disclosed in U.S. Pat. No. 6,565,880 directed to formulations of BIRB 796. One of the desirable characteristics of a preferred polymorph form is that it be more thermodynamically stable.